BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOL-X AORTIC DEVICE

    MDR report key: 3211107 · Received July 8, 2013

    Report

    Report Number
    3008500478-2013-00463
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K020693
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED.  THE PROPOSED ROOT CAUSE IS EVENTS RELATED TO THE PROCEDURE, DUE TO THE PATIENT ANATOMY. THE DOCTOR STATED THAT WHEN THE EMBOL-X DEVICE WAS REMOVED THERE WAS A ½ SUGAR CUBE SIZE CLOT CAUGHT IN THE NET. A CLOT THIS SIZE IS AN ABNORMAL OPERATIONAL EVENT. (NO OTHER REPORTS OF CLOTS THAT SIZE OR GREATER). IT IS SUSPECTED THAT THE DOCTOR BROKE THE PRONGS OF THE DEVICE WHEN HE WAS ATTEMPTING TO RETRACT THE FILTER, WITH THE LARGE CLOT. THE CLOT IS ESTIMATED TO BE LARGER THAN THE ID OF THE CANNULA SO IT WAS IMPOSSIBLE TO RETRACT THE FILTER INTO THE CANNULA. THUS APPLYING A VERY LARGE FORCE TO THE PRONGS HOLDING THE FILTER ON. HOWEVER OTHER POSSIBLE ROOT CAUSES INCLUDE, INCORRECT PREP OF DEVICE, DAMAGE UPON SHIPPING, DAMAGED DURING THE MANUFACTURING PROCESS.  THE MANUFACTURING TEAM WAS MADE AWARE OF THE COMPLAINT, IN ORDER TO INCREASE AWARENESS OF THE COMPLAINT, AND POSSIBLE DEFECTS. HOWEVER THE COMPLAINT DOES NOT WARRANT A CAPA. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS PHONED IN BY THE PERFUSIONIST THAT THE EMBOL-X AORTIC CANNULA FILTER GOT STUCK IN THE CANNULA DURING THE REMOVAL PROCESS. THE CASE WENT AS PLANNED UNTIL THE SURGEON WAS RETRACTING THE FILTER FROM THE CANNULA AT THE END OF THE CASE, HE FELT RESISTANCE. WHEN HE TRIED TO REMOVE THE DEVICE HE SAW ONLY TWO PRONGS ON THE FILTER. HE THEN STOPPED WITH THE REMOVAL PROCESS. AT THIS TIME, THE PATIENT'S ARTERIAL PRESSURE "FLAT LINED" AND THE PATIENT WAS PLACED BACK ON BYPASS. THE SURGEON USED ECHO AND OPENED THE PATIENT'S AORTA. UPON THIS HE FOUND THE FILTER'S NET HANGING BY TWO DISTAL PRONGS WITH A "1/2 SUGAR CUBE" SIZE BLOOD OR PLAQUE CLOT. "THE NET DID ITS JOB" AND THE SURGEON STATED THAT "IS WHY WE COULDN'T REMOVE THE FILTER." IT WAS REPORTED THAT THE PATIENT "DID NOT HAVE A HISTORY OF A-FIB OR CLOT IN VENTRICLES". PROTAMINE WAS NOT GIVEN. THE PACKAGE WAS NOT RETAINED, THE LOT NUMBER IS UNKNOWN. THE PATIENT IS "DOING FINE TODAY AND EXPERIENCED NO DEFICIT" AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311249 EMBOL-X AORTIC DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES EXGF24XLD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other